The Structured Product Label is consist of labelling information documented in U.S Package Insert (USPI) as well as additional information such as drug listing details. SPL is in XML format, and it is essential for format and layout the information. A style sheet provides the information to format the XML sheet. The ability to present labelling content stored in XML is done through sheets. Structured Product Label enables ensure uniform approach to label to a product. The standard format enables measurable improvements can be achieved through out the labelling process. SPL improved patient safety by providing the accurate information. It offers advantages such as exchange of labelling information and allows the content easily available. SPL promote the use of standard codes and terminology across the labelling content such as dosage forms, package types, indication, warning, ingredient names, and route of administration. Structured Product Label enables reduce the manual effort involved with approval of labeling of product. The technological advancements and innovations in the label management spur new opportunities for the companies the industry. Global Structured Product Label Management market is expected to offers lucrative market over the forecast period.
Structured Product Label Management Market: Drivers and restraints
The global Product Label Management market can be impacted by following drivers, the regulatory bodies imposed stringent regulation regarding the labelling of a pharma products. In February 2014, U.S. Food and Drug Administration (FDA) issued a draft guidance regarding the electronic submission of labelling content must be provided in XML based format known as Structured Product Label (SPL). This enables provide robust opportunities SPL market. The pharma companies are inclined towards innovative and rapid advanced technologies in label of a pharma product. Which enables propel the Structured Product Label Management market. Thus, in turn, would lead to increase in demand for Structured Product Label Management. However, the market is has a negative impact due to lack of skilled and trained professionals. This acts as bottleneck for the global Structured Product Label Management market.
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Structured Product Label Management Market: Segmentation
Global Structured Product Label Management market can be segmented as following types
By Product Type
- Software
- Installed Software
- Software-as-a Service
- Hardware
By End User
- Pharmaceutical Industry
- Biopharmaceutical Industry
- Contract research Organizations
Structured Product Label Management Market: Overview
Global Structured Product Label Management market is gaining upsurge across the globe due to stringent regulatory environment compels the pharma companies to adopt structured Product Labelling Management. The SPL allows more streamlined workflow of pharmaceutical product and enables easy access of information. The advantages of SPL attract the pharma players towards structured Product Label. The global Structured Product Label Management market expected to witness a significant CAGR as well as annual growth rates over the forecast period.
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Structured Product Label Management Market: Region-Wise Outlook
Global market is segmented into seven key regions, those are North America (N.A), Western Europe (W.E), Latin America (L.A), Eastern Europe (E.E), Asia-Pacific Excluding Japan (APEJ), Japan, and Middle East and Africa (MEA).
North America is anticipated to have a maximum market share in global Structured Product Label Management market due to higher adoption rate of advanced technologies in US and Canada. Asia Pacific follows North America in terms of market share in global Structured Product Label Management market owing to the drastic change in Asian countries economy as well as growth in generic pharma companies in the region, especially in countries like India, Japan, China. Europe is having a considerable contribution in global Structured Product Label Management market.
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Structured Product Label Management Market: Key players
Some of the key players are
- I4i, Inc.
- Intagras, Inc.
- Dakota Systems, Inc.
- RKE Holdings, LLC.
- Spectra Soft